Monday, June 16, 2014

Weekly FDA Enforcement Report For Drugs And Biologics 6/11/14

The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for June 11, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Biologics or Drugs and by Classification. 
Classification I Recall
A Classification I recall signifies a reasonable probability of serious adverse health consequences or death.
  • Biologics: No Class I biologics recalled this week.
  • DrugsHospira from Lake Forest, IL voluntarily issued a nationwide recall for Marcaine (bupivacaine HCl)injection, available by prescription only, due to a customer’s complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. The Class I drug is a local anesthetic that blocks the generation and the conduction of nerve impulses.
Classification II Recall
A Classification II recall signifies that the product may cause temporary or medically reversible adverse health consequences.
  • BiologicsLifeServe Blood Center from Des Moines, IA recalled Platelets Pooled Leukocytes Reduced due to a donor with possible variant Creutzfeldt-Jakob Disease (vCJD). It also recalled Red Blood Cells Leukocytes because of a donor that traveled to a malarial area. OneBlood, from Lauderhill, FL, recalled Red Blood Cells, Plasma, and Platelets due to an unsuitable donor. The Oklahoma Blood Institute - Sylvan N Goldman Center recalled Platelets Pheresis Leukocytes Reduced, Red Blood Cells Leukocytes Reduced Irradiated, and Red Blood Cells Leukocytes Reduced. The Pall Corporation recalled Sterile Cord Blood Collection Unit, Anticoagulant Citrate Phosphate Dextrose Solution (CPD) because of blood leaks. Other firms recalling Class II biologics are Innovative Blood Resources and Central Shared Services.
  • DrugsPfizer recalled the Greenstone Brand of fluconazole (Oral Suspension) due to a defective container, as the tamper evident rings failed on some bottles. Golden State Medical Supply of Camarillo, CA recalled Losartan Potassium tablets, available by prescription only, due to possible debris swept into the product during cleaning. Carefusion 2200 from Vernon Hills, IL recalled CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner (9 and 15 percent) due to less than potent iodine concentration.
Classification III Recall
A Classification III recall signifies that the product is not likely to cause adverse health consequences.
  • BiologicsBio-Save Resources of Albuquerque, NM initiated a recall in the United Kingdom for Source Plasma because the donor’s arm was not inspected.
  • Drugs: No Class III drugs recalled this week.

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